MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Model Number	08058687190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable triglyceride results from the cobas pro c 503 analytical unit.Patient 1 initial result was 438 mg/dl and the repeat results were 133 mg/dl and 132 mg/dl.Patient 2 initial result was 465 mg/dl and the repeat results were 221 mg/dl and 224 mg/dl.On (b)(6) 2023 ini tial result was 469 mg/dl and the repeat result was 82.3 mg/dl.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The cobas pro c 503 analytical unit serial number was (b)(6).The quality control results were acceptable.The field service engineer decontaminated the sample probe, cleaned the rinse station/wash station.He ran quality controls and precision testing which passed.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.A general reagent or analyzer problem was not present, because the qc results were within range.
Additional Manufacturer Narrative
Udi related data quality updates only d3 is the initial distributor in the us.

• Brand Name: TRIGLYCERIDES
• Common Device Name: TRIGLYCERIDES ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18335305
• Report Number: 1823260-2023-04029
• Device Sequence Number: 15575470
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 08058687190
• Device Catalogue Number: 08058687190
• Device Lot Number: 73558801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 08/29/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 12/20/2023; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown